FDA Registration
Active
🇫🇷 France
Albumin, 12 x 20 mL, REF ALBU-0250-NA
Reg #: 3007662974
·
FEI: 3007662974
·
Expires 2025
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- VitalScientific
- Registration Number
- 3007662974
- FEI Number
- 3007662974
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zone Industrielle, 13 rue Auguste Mottin
- City
- SEES Normandie
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K110830
Owner / Operator
- Firm Name
- VitalScientific
- Operator Number
- 10090892
- Address
- 13 Rue Auguste Mottin - Zone Industrielle
- City
- SEES
- State
- Orne
- Postal Code
- 61500
- Country
- FR
- Correspondent
- Valerie LAMBERT
US Agent
- Business Name
- Clinical Diagnostic Solutions, Inc
- Contact Name
- Junelle Goldson
- Address
- 1800 Nw 65th Ave
- City
- Plantation
- State
- FL
- ZIP
- 33313
- Country
- US
- [email protected]
- Phone
- 954 7911773
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2024-05-31 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2024-05-31 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2024-05-31 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2024-05-31 |
Proprietary Names
Albumin, 12 x 20 mL, REF ALBU-0250-NA
ELITROL II, 10 x 5 mL, REF CONT-0180
ELICAL 2, 4 x 3 mL, REF CALI-0580
ENVOY 500 Albumin Reagent Kit, REF 55225
CALCIUM ARSENAZO, Ref.CALA-0250
ELITROL I, 10 x 5 mL, REF CONT-0080
Establishment Types
Manufacture Medical Device